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Clinical Trials in China / NCT06810791
Recruiting Phase 3

HVA vs IA/DA or VA in the Treatment of ND HR-AML

NCT06810791 · tracked via the Priya Life Science China tracker
Sponsor
Nanfang Hospital, Southern Medical University
Phase
Phase 3
Started
2025-01-01
Last updated
2025-02-06

Condition(s) studied

Newly Diagnosed Acute Myeloid Leukemia With High Risk

Investigational drug(s) / intervention(s)

HVAVA →Standard Chemotherapy

HVA: Homoharringtonine (HHT) is given by venous drip daily at 1 mg/m2 from day 1 to 7. Venetoclax (VEN) is given 100 mg on day 1, 200 mg on day 2, and 400 mg orally from day 3 to day 14. Azacitidine (AZA) is given 75 mg/m2 subcutaneously from day 1 to 7.

VA: VEN is given 100 mg on day 1, 200 mg on day 2, and 400 mg orally from day 3 to day 28, and AZA (75 mg/m2) is given subcutaneously from day 1 to 7.

Standard Chemotherapy: Standard Chemotherapy includes IA(Idarubicin combined with Cytarabine) or DA(Daunorubicin combined with Cytarabine). IDA is given by venous drip daily at 12mg/m2, or DNR is given by venous drip daily at 60mg/m2, from day 1-3, combined with Ara-C at 100mg/m2 by continuously venous drip from day 1-7.

Study summary

The aim of this study is to evaluate the safety and efficacy of homohartonine combined with venetoclax and azacitidine (HVA) versus intensive chemotherapy (IA/DA) or venetoclax combined with azacitidine (VA) in newly diagnosed high-risk AML patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * According to the world health organization (WHO) classification of newly diagnosed with AML patients; * Age ≥18 years old; * High-risk patients should meet any of the following criteria: ① High risk group according to the European Leukemia Risk stratification (ELN) 2022; (2) Secondary AML (sAML) which develops from myelodysplastic syndrome (MDS), bone marrow hyperplastic tumor (MPN) or chronic myeloid cell leukemia, et.; (3) Treatment-related AML (t-AML), Patients have a history of cytotoxic treatment record or ionizing radiation therapy. * Patients did not receive anti-AML therapy (except leukopenia therapy, such as hydroxyurea or cytarabine \< 1.0g/d) after the diagnosis of AML; * Expected survival ≥12 weeks; * The eastern tumor cooperation group (ECOG) score 3 points or less; * Kidney function: creatinine clearance acuity 30 ml/min; * Liver function: ALT \< 5 times normal value, bilirubin \< 3 times normal value; * Sign the informed consent form and understand and abide by the plan calls for process. Exclusion Criteria: * Acute promyelocytic leukemia; * With central nervous system leukemia (CNSL) ; * The cardiac function \> level 2; * The AIDS virus (HIV) infection; * Other clinical significance of uncontrolled condition, including but not limited to: (1) out of control, or active systemic infection (viruses, bacteria or fungi); (2) chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; (3) need to actively deal with the merger of the second tumor; * Can't take oral treatment or having a gastrointestinal disease impact ing the absorption; * Being allergy to the experimental drugs; * Pregnant and lactating women; * Patients who could not understand or adhere to the study protocol; * Patients deemed by the investigator to be ineligible for enrollment.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Hematology,Nanfang Hospital, Southern Medical University Guangzhou Guangdong Recruiting

More Nanfang Hospital, Southern Medical University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06810791 on ClinicalTrials.gov ↗ ← All trials in China